The EU member states have so far been the dark horse in the discussions surrounding the revision of the EU medical devices directives, keeping their cards close to their chest and not getting involved in the largely fact free politics surrounding the ENVI rapporteurs’ drafts for the medical devices and IVD regulations.
Council of Employment, Social Policy and Health Ministers
With the Council of Employment, Social Policy and Health Ministers today and yesterday in Luxembourg it has just become a lot more transparent where the member states are on the revision. On the occasion of that council meeting the Presidency presented Progress Reports on the clinical trials proposal and the medical devices package.
The progress report for the medical devices package and its corrigendum show that the council has been doing a lot of preparatory work behind the scenes and has had a lot of meetings in committees already. This is why I think that this rather summary progress report shows only some of the Council’s cards, but not all by a long stretch. The facts that basically all council delegations have entered scrutiny reservations shows that they consider this no small matter and that they reserve the right to phone home and get support on a national basis. In practice however this rarely seriously hampers progress of EU legislation and it is expected it won’t in this case either.
Cards of the Council
What is the Council willing to show so far? Let’s take a look at the points in the progress reports:
- No splitting up of the regulations and no watering down to directives – this shows that the member states are serious about a more unitary medical devices market in the EU.
- The delegations think quite differently about the scrutiny mechanism proposed by the Commission and don’t even address the PMA proposal put forward by Mrs. Roth-Behrendt, which may well mean the member states appreciate that proposal as the political overshooting that the rapporteur itself admitted that it is.
- With respect to notified body oversight “the division of responsibilities between Member States and the Commission in designating a notified body remains to be clarified”, i.e. “we don’t like the Commission’s peer review of member states’ plans to accredit notified bodies”. Big surprise that they are critical about this (not) because they are handing over sovereignty. However, it does show that member states seem willing to resolve an important weakness in EU medical devices law: member state oversight of the notified bodies.
- The member states like the IVD regulation proposal’s adoption of the GHTF classification methodology for IVDs. To be expected, because the GHTF did not decide things that its state members did not like very much.
- Regarding clinical investigations for medical devices the member states are generally not happy with the short deadlines and silent approval for certain trials if the member states don’t act. Not surprising as well, because member states typically don’t like it if Europe is telling them to get a move on in the interest of the internal market.
The Council itself stated in its press release following the meeting on 21 June (p. 23):
“In its examination of the proposals the Council’s working party on pharmaceuticals and medical devices has so far identified the following main difficulties:
· the procedures for clinical evaluation;
· the method for strengthened control by notified bodies.”
Does that mean that they the council does not consider scrutiny a problem after all? Or that it considers it an issue it think it will be able to compromise on no matter what? Out of the three points of controversy in the progress report mentioned above this is the only one not mentioned as “main difficulty”.
Known knowns and known unknowns and a look in the crystal ball
With that, we still don’t know very much except some very cautious open ended support for the Commission’s proposal. We do know that the member states still have a lot of details to discuss with each other and with the Parliament. In so far as this has not started yet, it will pick up momentum after the vote on the ENVI amendments on 10 July that will form the basis for the Parliament’s plenary vote, planned for right after summer on 9 September. The big question is still whether the member states will be quick enough to finalise the project before the May 2014 elections, because if they don’t this may delay the progress of the project considerably.
On PMA, the big political bone of contention I personally think that the Council already has an idea where it wants to go with scrutiny/PMA and that is adopting scrutiny with perhaps some minor tweaks. PMA for devices is too costly, complex and will result in tying up too much national resources in EU procedure. They would rather have industry solve it by picking up the bill for the costs of the ‘notified bodies 2.0’ with more in-house experts and surprise inspections, under the assumption that this should be enough of a concession to the public to address the criticism on notified body performance. On the other big point of reprocessing the Council has not shown what it thinks at all. By explicitly backing the Commission’s proposal it is taking a preliminary stance vis-a-vis anything that ENVI cooks up in the end, and seems to position itself on the other side of the spectrum to make sure that the compromises that the rapporteur already announced will land closer to the Commission proposal, even if the negotiations with Parliament are only starting formally after the plenary vote on 9 September.
IMCO, the Internal Market Committee of the Parliament, has in the mean time voted to support Norra Berra’s (IMCO’s rapporteur) report plus the IMCO amendments for the regulation. These contain no PMA, but only support scrutiny and do not contain the crazy mechanism for reprocessing. This shows that the Parliament does not universally back the proposals of rapporteur Roth-Behrendt, as was already quite clear, which may result in some compromises with a view to the plenary vote.
That’s as far as my crystal ball goes for the moment. But let’s see what happens on 10 July in the ENVI vote because that will define the summer’s political landscape.